FDA News

FDA approves implantable drug delivery system for PAH

Medtronic announced that an implantable drug delivery system and cardiac catheter technology for the treatment of patients with pulmonary arterial hypertension has received approval from the FDA.

The system (SynchroMed II, Medtronic) is used to deliver treprostinil (Remodulin, United Therapeutics) in patients with PAH who have previously been receiving the injection, according to a press release from Medtronic.

“External infusion pumps have been used to deliver prostacyclins for PAH, but managing the therapy places a significant burden on patients, interferes with their daily activities and runs a high risk of infections,” David Steinhaus, MD, general manager of the heart failure business within the Cardiac and Vascular Group at Medtronic, said in the press release. “This fully implantable drug delivery system was designed to address these serious patient care concerns.”

Approval of the system was based on the DelIVery for PAH trial, which found that the system was successful in delivering treprostinil in 60 patients with a high rate of patient satisfaction and a low rate of catheter-related complications, according to the release.

The commercial promotion of the implantable system will be led by United Therapeutics with support from Medtronic, according to the release.

Disclosure: Steinhaus is an employee of Medtronic.

Medtronic announced that an implantable drug delivery system and cardiac catheter technology for the treatment of patients with pulmonary arterial hypertension has received approval from the FDA.

The system (SynchroMed II, Medtronic) is used to deliver treprostinil (Remodulin, United Therapeutics) in patients with PAH who have previously been receiving the injection, according to a press release from Medtronic.

“External infusion pumps have been used to deliver prostacyclins for PAH, but managing the therapy places a significant burden on patients, interferes with their daily activities and runs a high risk of infections,” David Steinhaus, MD, general manager of the heart failure business within the Cardiac and Vascular Group at Medtronic, said in the press release. “This fully implantable drug delivery system was designed to address these serious patient care concerns.”

Approval of the system was based on the DelIVery for PAH trial, which found that the system was successful in delivering treprostinil in 60 patients with a high rate of patient satisfaction and a low rate of catheter-related complications, according to the release.

The commercial promotion of the implantable system will be led by United Therapeutics with support from Medtronic, according to the release.

Disclosure: Steinhaus is an employee of Medtronic.